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USP 661 Plastic Packaging Testing

EuTech Scientific has the analytical capabilities, expertise and experience to meet all your <661> challenges.

The US Pharmacopeia has established USP <661> as a set of standards to test the suitability of therapeutic product packaging and their associated materials and components of construction. The plastics which are being used in therapeutic products comprise of many homologous polymers. The amount of additives in the plastic depends on the type of polymers used, and the processes used to convert  these polymers into the finished packaging systems.

Contact between the therapeutic products and these packaging systems can result in many different interactions. It is imperative that these interactions do not alter the safety and efficacy of the therapeutic product. For this reason, it is necessary to perform thorough characterization of these materials.

USP <661> includes:

  • USP <661.1> Plastic Materials of Construction : This chapter contains tests, methods, and specifications for the following materials:
  1. Cyclic Olefins,
  2. Polyethylene
  3. Polypropylene
  4. Polyethylene Terephthalate
  5. Polyethylene Terephthalate G
  6. Plasticized Polyvinyl Chloride

 

  • USP <661.2> Plastic Packaging Systems for Pharmaceutical Use: This chapter provides the methods and specifications for testing the final packaging system. The scope of these tests include but are not limited to:
    1. Bags
    2. Bottles
    3. Vials
    4. Ampoules
    5. Cartridges
    6. Dry powder and metered dose inhalers
    7. Syringes

Furthermore EuTech can perform a full scale Extractables and Leachables assessment to ensure that the products are suitable for their use employing the latest FDA guidelines.